Edwards plans to spin off critical care business next year

December 11, 2023  Source: drugdu 102

BY SEAN WHOOLEY
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Edwards Lifesciences (NYSE: EW)+ announced today that it intends to spin off its critical care business by the end of 2024.
The company shared a number of key plans going forward as it outlined its plans for future growth. Among its plans, Edwards expects to spin off the critical care unit and its full range of smart monitoring technologies next year.
“During 2024, Edwards plans to support the growth and leadership of innovations in advanced patient monitoring, with the goal of improving the quality of care for millions of patients annually,” Edwards wrote in a news release.
Analysts expect shares of Edwards to move up on the news today. Shares of EW rose 1% at $70.17 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remained even.
Edwards intends to complete the spin-off tax-free. The company said it enables it to sharpen its focus on expanded opportunities in cardiovascular and surgical areas. It singled out transcatheter aortic valve replacement (TAVR), transcatheter mitral and tricuspid therapies (TMTT) and surgical. Edwards also plans to invest more in interventional heart failure technologies.
According to the company, the spin enables increased focus and flexibility for the critical care unit. It will continue to seek to advance AI-enabled smart monitoring solutions. Edwards tabbed Katie Szyman, corporate VP of critical care (since 2015) to lead the new company as CEO when the spin completes.
“We are proud of the critical care team, its rich legacy of pioneering innovation and the contributions they have made to our company, and we look forward to an even stronger future for Critical Care,” said Bernard Zovighian, Edwards CEO.
Other highlights for Edwards
Key points announced by Edwards include the expectation of U.S. approval for the Evoque tricuspid valve in Europe by mid-2024. Evoque won CE mark in October and the company also plans to kick off European commercialization efforts for it next year.
Edwards anticipates CE mark for its Sapien M3 TMTT device by the end of 2025. It plans to complete early enrollment in an aortic stenosis treatment trial in early 2024. The company expects EARLY TAVR data studying aortic stenosis patients at TCT 2024.
Additionally, Edwards wants to continue expanding its Pascal commercialization in the U.S. and Europe. It plans to launch in Japan soon as well.
Edwards reaffirmed its 2023 guidance and projects 8%-10% growth in 2024, with revenues between $6.3 billion and $6.6 billion. It set 2024 guidance for adjusted earnings per share for between $2.70 and $2.80. Edwards expects TAVR sales to land between $4 billion and $4.3 billion and TMTT sales to bring in $280 million to $320 million.
“We expect our sharpened focus in structural heart to drive sustainable growth in the years to come as we embark on a new era of innovation to address large unmet patient needs,” Zovighian said. “I’m pleased with our performance in 2023 as we have reinforced our TAVR leadership position with new clinical evidence and reached an inflection point with new approved mitral and tricuspid technologies. In 2024, we are projecting strong sales growth and look forward to launching breakthrough technologies and progressing on multiple important clinical trials.”

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